7 Testing and Maintenance
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If you combine a medical device with a medical or non-medical device to form a medical electrical
system according to IEC 60601-1:2005+A1:2012/EN 60601-1:2006+AC:2010 using two separate
protective earth connections and one of the devices is located in a non-medically used room creating a
potential voltage difference, additional protective measures are required, e.g. usage of a separation
device or additional protective earth connection. The medical electrical devices or IT equipment may
be located in or outside the patient vicinity. After system installation incl. protective measures, a system
test is required to ensure that the resulting equipment leakage current does not exceed the limits of
IEC 60601-1:2005+A1:2012/EN 60601-1:2006+AC:2010.
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